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FDA 510(k)

OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM

K-Number: K894977 · 1989-10-10

ApplicantTrimedyne, Inc.
Decision Date1989-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K894977. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM?

OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Trimedyne, Inc.. The 510(k) number is K894977.

When did OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1989-10-10, under 510(k) number K894977.

Who is the listed applicant for OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM?

The FDA 510(k) record lists Trimedyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM?

The FDA product code for OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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